BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1033146 · Received April 22, 2008

    Report

    Report Number
    1644487-2008-00980
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    January 18, 2008
    Report Date
    April 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MDR REPORT NUMBER: 1644487-2008-00980. THE PT'S GENERATOR WAS REPLACED FOR NEARING END AND BATTERY LIFE. MFR NOTED DURING ANALYSIS A Q10 FAILURE. A GENERATOR PRODUCT ANALYSIS WAS PERFORMED. THE ELECTIVE REPLACEMENT INDICATOR YES STATUS WAS VERIFIED AND THE DEVICE CONTINUED TO FUNCTION. AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE LEVEL VERIFIED THAT THE ELECTIVE REPLACEMENT INDICATOR STATUS WAS YES AND THAT THE BATTERY WAS PARTIALLY DEPLETED. THE GENERATOR FAILED THE POST BURN ELECTRICAL TEST. ANALYSIS IDENTIFIED THE Q10 COMPONENT TO BE THE ROOT CAUSE OF THE POST BURN-IN ELECTRICAL TEST FAILURE. THE Q10 WAS REPLACED WITH A KNOWN GOOD BENCH Q10. AFTER THE Q10 WAS REPLACED, THE DEVICE WAS TESTED WITHIN SPECS FOR THE POST BURN-IN ELECTRICAL TEST. NO VISUAL OR MECHANICAL ANOMALY WAS IDENTIFIED THAT COULD IMPACT DEVICE PERFORMANCE. ANALYSIS FOUND THAT THE DEFECTIVE Q10 DID NOT IMPACT DEVICE PERFORMANCE. THE Q10 FAILURE WOULD LIKELY HAVE HAD A MINIMAL IMPACT ON THE BATTERY LONGEVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1353

    Patients

    Seq Age Sex Outcome Treatment
    1